Stent system enhances quality of life for patients with deadly and
increasingly common esophageal tumors

November 08, 2010 08:30 AM Eastern Standard Time

WINSTON-SALEM, N.C.--(BUSINESS WIRE)--Cook Medical’s controlled-release esophageal stent fully covered in
silicone has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA), making available yet another advanced solution
from Cook Medical, the only full-line supplier of endoscopic devices.
The Evolution® Controlled Release Esophageal Fully Covered
Stent is designed to improve quality of life for patients with malignant
esophageal strictures and tracheoesophageal fistulas (TEF) by improving
the patients’ ability to swallow, and its silicone that fully covers the
stent helps prevent tumor ingrowth. In addition, the system gives
physicians unparalleled control during stent deployment and recapture.

Esophageal cancer is among the most rapidly increasing malignancies in
North America. More than 16,500 new cases of esophageal cancer are
diagnosed annually in the U.S., most associated with risk factors such
as alcohol consumption, tobacco use, GERD (gastroesophageal reflux
disease) and obesity1. The vast majority of patients die
within a year of diagnosis. An esophageal stent is typically used to
open a passage obstructed by a tumor that has advanced beyond surgical
treatment. The stent improves the patients ability to eat and swallow,
allowing them to maintain a better quality of life even in the end stage
of the disease. Stents are also used to treat TEF (tracheoesophageal
fistula), an abnormal connection between the trachea and esophagus that
can occur congenitally or develop in adults after laryngeal surgery.

“The Evolution Fully Covered Stent offers physicians more control and
less stress in stent placement and recapture,” said Barry Slowey, global
business unit leader for Cook Medical’s endoscopy division. “The
addition of the fully covered stent to Cook's existing Evolution product
line provides more options to physicians to treat their esophageal
cancer patients.”

The Evolution Fully Covered Stent is an esophageal stent with silicone
internal and external of the stent that resists tumor ingrowth and makes
swallowing more comfortable for the patient. It’s also easier to place
because the physician does not have to deduce where the covering ends to
position it properly in the center of the tumor. The fully covered
Evolution is also designed to secure the stent in the esophageal tract,
potentially reducing the risk of stent migration after placement and
eliminating the need for repeat procedures.

The Evolution Fully Covered Stent builds on technology introduced with
the Evolution® Controlled Release Esophageal Stent, which
received 510(k) clearance in May 2008. That design employed the first
and only delivery system to enable controlled release and
recapturability featuring a “point-of-no-return” indicator. With each
squeeze of the stent system’s trigger-based introducer, a proportional
length of the stent is deployed or recaptured. The directional button
switches smoothly from deployment to recapture mode, and the
“point-of-no-return” mark alerts the physician when recapture is no
longer available – repositioning, however, is still an option.

About Cook Medical

Founded in 1963, Cook Medical pioneered many of the medical devices now
commonly used to perform minimally invasive medical procedures
throughout the body. Today, the company integrates medical devices,
drugs and biologic grafts to enhance patient safety and improve clinical
outcomes. Since its inception,Cook has operated as a family-held
private corporation. For more information, visit www.cookmedical.com
<http://www.cookmedical.com/>.
Follow Cook Medical on Twitter @cookmedicalpr and @cookgastro.